1 year contract validation engineer ($4K to $5K) - Medical Device

• Provide guidance on planning and execution of validation projects for manufacturing equipment, processes and facilities
• Lead development of validation strategies and guide validation planning
• Work with cross-functional teams on preparation and execution of validation activities
• Review validation protocols and reports; provide QA support
• Manage IFC quality engineering and lead / participate in investigation and implementation of corrective and preventive actions for customer complaints and non-conforming products, and follow up on proper closure with verification of effectiveness.
• Collaborate with HQ, Tech Support and cross functional teams on customer complaints and respond to inquiries as needed.
• Ensure proper documentation of customer feedback and analyse failure trends to identify improvement actions.
• Manage records and tracking of reports from quality sub-systems such as Non-Conformance Request (NCR), Corrective Action (CA), and Preventive Action (PA) and ensure timely closure.
• Analyze quality monitoring data, trend performance, and prepare reports to communicate results of quality assurance activities.

Minimum Qualifications

• Min Bachelor’s Degree in Engineering, Science, Biotechnology or related fields.
• 5+ years’ experience in validation and QA in medical device manufacturing.
• Thorough knowledge and understanding of ISO 13485 and cGMP/QSR, validation principles, and applicable regulations related to validation principles.

Interested candidates, please forward your resume to [Click Here to Email Your Resume] 

Consultant: Huang Jingsheng Kevyn (R1333338) 

Recruit Express Pte Ltd (99C4599)